1. Field of the Invention
The present invention relates generally to the field of nasal packing devices, and more particularly, to a nasal packing device that includes an anterior and a posterior bag on a structural tube to allow insertion into a patient's nasal cavity. The two bags are fabricated from a relatively inelastic material, are oversized to provide a fixed surface area that defines a bag volume that is larger than the nasal cavity volume, and are independently inflatable via lumens in the structural tube initially at a relatively low fill pressure to cause the bags to fill slowly to contact all or most of the nasal cavity surfaces and then once positioned and shaped at a higher contact or force-applying pressure to stop anterior and/or posterior epistaxis (e.g., using pressures directly contrasting with balloon inflation which requires high initial pressures to initiate elastic material stretching).
2. Relevant Background
Physicians are frequently called upon to treat nasal bleeding, i.e., epistaxis, that can be caused by tissue desiccation, trauma, disease, or surgical procedures. Epistaxis can produce rapid, extensive blood loss because of the extensive blood supply to the nose, and in some cases, blood transfusion may be required to treat the patient. Due to the seriousness of some cases of epistaxis, the physician's first concern is to control the bleeding as quickly as possible. The physician needs to be able to efficiently and accurately insert the nasal packing or nasal packing device into the correct position and to then use the packing or operate the device to stop or at least control bleeding.
The problem of epistaxis treatment is complicated by the fact that nasal bleeding can occur at any of a variety of locations within the nasal cavity. FIG. 1 illustrates generally the human nasal cavity and indicates the location of the major portions of the nasal cavity, i.e., the anterior nasal cavity, the posterior nasal cavity, and the nasopharynx. In practice, anterior epistaxis generally arises from the septum, the floor of the nose, or the turbinates which are along the outer wall of the anterior nasal cavity. Posterior epistaxis occurs within the posterior nasal cavity typically near its junction with the nasopharynx. The problem with treating epistaxis is further complicated by the limited visibility afforded the physician within the narrow, dark nasal cavity, particularly if bleeding is profuse. Because of these limitations, it is difficult for the physician to determine whether the nasal packing or nasal packing device has been properly positioned, which may result in repeated packing procedures with different devices. Such trial and error techniques are undesirable because of the loss of blood and wasted time. Also, the insertion of nasal packing and packing devices is often painful and uncomfortable for the patient; and when the nasal packing or packing device must be repositioned or reinserted unnecessary pain and discomfort is inflicted on the patient.
A wide variety of nasal packing devices have been developed in an attempt to control nasal bleeding, but unfortunately, none of these devices has met the needs of physicians for ease of use and effectiveness while also providing patients with a less painful treatment. One relatively effective technique for stopping nasal bleeding is with the use of gauze, but this technique typically is relatively slow, as a very large amount of gauze may need to be inserted to control the bleeding, e.g., commonly six feet of gauze. The insertion and removal of the gauze can also be painful and uncomfortable for the patient, with some patients requiring anesthesia or other pain inhibitors.
To address the problems with using gauze, a number of inflatable nasal packing devices have been developed, but again these devices have not met all of the needs of physicians and patients. For example, many devices have been developed and used that provide one or two inflatable members or sleeves. In some devices, one inflatable member is positioned in the anterior nasal cavity and the other is located in the nasopharynx. Each inflatable member is typically formed of elastic material and can be thought of as a balloon. While providing some control over nasal bleeding, devices utilizing balloons typically are ineffective in reaching all areas of the irregularly shaped nasal cavity and typically cause a patient a significant amount of pain during inflation.
More specifically, an elastic balloon does not readily conform to the convoluted surface (turbinates) of the lateral nasal wall or to septal deviations because the wall of a balloon becomes relatively rigid early in the inflation process and becomes progressively stiffer with continued inflation. The initial and continued wall stiffness substantially reduces the effectiveness of a balloon in controlling bleeding from the turbinates and septal concavities. Some of these balloon nasal packing devices have been developed in an attempt to stop posterior epistaxis by compressing the main artery to the interior of the nose (i.e., the sphenopalatine artery) as it enters the nasal cavity and before it forms any branches. However, presently available balloon devices do not address posterior epistaxis caused by branches of the anterior and posterior ethmoid arteries. These devices fail to address the problem that a spherical balloon does not readily conform to the non-spherical anatomy of the nasopharynx and posterior nasal cavity.
Further, the typical balloon or elastic device fails to address problems in controlling epistaxis in patients with deviated septums. The balloon nasal packing devices are relatively effective for treating anterior epistaxis arising from a nasal septal site that is directly compressed by the inflated anterior balloon. However, the effectiveness is limited to the situation in which the septal bleeding site directly matches the generally spherical contours of the inflated balloon. That is, the balloon wall can only compress a bleeding site in the mid-portion of a substantially planar or mildly concave or convex septal deviation as can be seen in FIG. 2. Additional limitations for balloon wall contact exist when the septum exhibits a more remarkable degree of deviation, which is a common finding in the epistaxis patient. A septal deviation is characterized as a convexity, concavity, bone spur, or bone crest as can be seen in FIG. 2. It is at a site of septal deviation that high local airflow turbulence occurs. Mucosal dessication, erosion, and subsequent bleeding are more likely to occur at such a site than in an area of smooth, laminar airflow over a midline planar mucosal surface. Similarly, more posterior nasal sites of high local airflow turbulence are predisposed to epistaxis. FIG. 2 illustrates the lack of contact between the inflated balloon and the concave portion of the septum. Hence, the elastic balloon devices are least effective in areas of the nasal cavity where bleeding is expected to occur in patients with deviated septums.
The use of balloon nasal packing devices has also proven to be very painful to epistaxis patients. Generally, the pain is caused by the high pressure required to inflate the balloon and to force it to fill at least portions of recessed or irregular surfaces within the nasal cavity. As can be understood by anyone who has blown up or inflated a child's balloon, a relatively high pressure is required to initiate the initial stretching of the balloon material. Typically, this initial high pressure must be maintained for at least a period of time to keep the material stretching such that the balloon takes an inflated volume that is pressure dependent, e.g., the balloon wall initially defines a relatively small volume but later defines an inflated volume that depends directly on internal gas pressures and wall material and thickness. The balloons are typically sealed circumferentially to the tube used for inserting and supplying inflating gas to the balloons. With this type of attachment, the balloons typically stretch outward radially from all sides of the tube to initially form an enlarged tube with a circular cross section that increases in diameter at larger distances from the seal locations. Hence, the shape the inflated balloon attempts to form is very different from the irregular nasal cavity of the typical patient shown in FIGS. 1 and 2.
With specific reference to nasal packing devices, the balloon wall exerts the initial high fill pressure outward against any portion of the nasal cavity contacting the balloon exterior, causing the patient pain. The high pressure also typically makes it difficult for the balloon to conform, due to wall rigidity, to irregular shapes and generally to any shape that is not relatively spherical or smooth. With reference to FIG. 2, the relatively rigid balloon wall exerts an especially high pressure point against any projecting septal deformity, which, in turn, causes greater pain for the epistaxis patient. When bleeding occurs at a recess lying under a septal spur or crest, markedly higher inflation pressure is required to stretch the balloon wall toward that recess, thereby, causing the patient even more pain while typically still not providing an adequate contact pressure upon the bleeding site. If contact is not achieved, the pressure must be increased in an attempt to force the balloon into crevices.
Hence, there remains a need for an improved inflatable nasal packing device that addresses balloon-associated high inflation pressure requirements, limitations in reaching recessed bleeding sites, and unacceptably high treatment-induced patient pain levels. Preferably such a device would be easy for a physician to insert, to operate, and to remove while also reducing the amount of discomfort and pain experienced by the patient during and after treatment, e.g., during removal of the device.